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Probiotics and Overreaching Recovery

Sponsor
University of Padova (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04885010
Collaborator
(none)
16
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Overloading is a key training principle used by athletes and coaches to improve physical performance. Intensified training periods are therefore commonly incorporated into the course of a regular training season. From a clinical point of view, very intense periods of training are associated with a temporary immunological deficiency which can lead to teh "overreaching syndroms".

During periods of overreaching, nutritional strategies are mainly aimed at ensuring sufficient amounts of energy to support the increase in effort. However less is known about nutritional supplements to attenuated the inflammatory/immunological response to training stress.

Probiotic bacteria are defined as live food ingredients beneficial to the host's health. Numerous health benefits have been attributed to probiotics, including effects on gastrointestinal tract function and disease, immune function, hyperlipidemia, hypertension, and allergic conditions. Studies in the literature on the ergogenic effect of probiotics in athletes are still scarce today. this study aims to explore the potential role of probiotics on performance, recovery from fatigue and immune function during intensive period of training.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: probiotics
  • Dietary Supplement: placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Probiotics for Athlete's Recovery and Immune System
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotics

participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching.

Dietary Supplement: probiotics
participants will be given probiotics twice a day for 15 days
Placebo Comparator: Placebo

participants will train for 15 days while consuming the dietary supplement. During the last 8 days the intensity of training will increase to induce overreaching.

Dietary Supplement: placebo
participants will be given a placebo twice a day for 15 days

Outcome Measures

Primary Outcome Measures

  1. lymphocyte subpopulation total T (CD3+) [Change from baseline to up to 15 days]

    lymphocyte subpopulation: total T (CD3+) %

  2. T-helper (CD4+) [Change from baseline to up to 15 days]

    lymphocyte subpopulation: T-helper (CD4+) %

  3. T-suppressor (CD8+) [Change from baseline to up to 15 days]

    lymphocyte subpopulation: T-suppressor (CD8+) %

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • age 25-55 years

  • Body mass index:> 18 and <30 kg / m2

  • Stable body weight for at least 3 months

  • regular practice of physical activity for at least 2 years

Exclusion Criteria:

  • Chronic diseases (cardiovascular, hepatic, respiratory, cancer)

  • Acute inflammatory states, infections or other pathologies

  • Regular use of probiotics

  • Use or treatment with steroids (within the previous 3 months)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Padova
ClinicalTrials.gov Identifier:
NCT04885010
Other Study ID Numbers:
  • PARIS
First Posted:
May 13, 2021
Last Update Posted:
May 13, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fatigue

Study Results

No Results Posted as of May 13, 2021